Ross Swanson is an Executive Vice President and Amy Newell is a Vice President at Corazon, Inc., offering strategic program development for the heart, vascular, neuro, and orthopedic specialties. To learn more, visit www.corazoninc.com or call (412) 364-8200. To reach the authors, email rswanson@corazoninc.com or anewell@corazoninc.com.

The cardiac landscape is changing, and while this has been a consistent and continual trend, recent regulatory activity in many states across the country has been particularly significant, especially related to PCI at facilities without on-site OHS. This topic has sparked great debate over the past decade, or even longer, though steadily this clinical practice has become more widely accepted nationally.

Changing practice trends

As more hospitals seek to offer PCI with OHS off-site, clinical guidelines based on standards from the national professional societies have been established to ensure that best practices for physicians, clinicians, and facilities are met or exceeded as a means to increase access to this vital care while preserving patient safety.

Unfortunately, existing regulations in various regions of the country often limit access to this life-saving therapy, which results in different standards of care based on patient location. But, fortunately, our extensive national experience demonstrates that a rapid paradigm shift is occurring. Across the country, we find the provision of angioplasty services with surgery off-site to be more widely accepted — a position well supported by the current 2011 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions PCI guidelines that were updated in 2013 with Primary PCI with OHS off site garnering a less restrictive Class IIa recommendation (weight of evidence is in favor of usefulness) and Elective PCI now listed as a Class IIb recommendation (usefulness/efficacy is less established) when it was previously fully restricted under a Class III recommendation (conditions where the treatment may pose harm).

As a means to support regulatory change related to PCI services, over the past 10 years, Corazon has been involved with the development of a hospital consortium approach in several states, including Pennsylvania, Georgia, Florida, Michigan, and Kentucky, to bring hospital leaders together to better affect positive change. We have seen a transition into acceptance across the country that has, in many cases, given rural community hospitals the opportunity to offer elective and emergent (primary) PCI. Corazon has served as an industry resource for both hospitals and state regulatory agencies as they work to understand how to implement the necessary structure and processes within PCI programs to provide the oversight required to ensure patient safety.

The Pennsylvania perspective

For many years, Corazon’s home state of Pennsylvania supported PCI with off-site OHS, but limited the number of facilities able to provide this level of service. Hospitals were mandated to participate in either the CPORT-E registry or a Pennsylvania state-specific demonstration project, both of which have since concluded. Since the Pennsylvania Department of Health (PADOH) already provided these options, in their absence, significant uncertainty emerged around how the hospitals would maintain a PCI program, or how new hospitals could begin to offer these life-saving services.

In the summer of 2012, as a result of a PA Consortium of hospitals, the PADOH responded to the request for an amendment/change within the state regulations that would allow community hospitals in Pennsylvania to consider expansion to PCI without the need to expand to on-site OHS as well. This process required the continued support and involvement of select hospitals who positioned themselves as a strong voice as part of the PA Consortium. Continuing through the fall of 2012 and spring of 2013, Corazon provided the PADOH with expert resources and education as to national trends in PCI, and provided references to contacts within other states related to our involvement with health departments and/or state agencies that affected regulatory change.

As time quickly passed, and through a comment period, the PADOH proposed a draft of the PA PCI exception procedures language that was finalized and published in January 2014. Now, the PADOH does allow hospitals in the state to offer PCI without OHS as part of an exception procedure to the existing regulations. Moving forward, all PCI programs with off-site OHS, including prior demonstration project participants and past CPORT-E participants, are required to re-apply to offer PCI services through a new Exception Request before December 31, 2014.

There are, however, expectations associated with this positive change across the state. Through the development of the current PCI Exception Procedures, opinions from national professional organizations, current and future hospital PCI providers, as well as nationally-renowned interventional cardiologists were solicited in an effort to obtain multiple perspectives about the ideal requirements that would improve access, while keeping clinical quality and patient outcomes as the key priorities.

Today, and for many years, volume has been the most sensitive (and debated) issue for hospitals seeking to expand services in their existing diagnostic cardiac cath labs. As part of the PA PCI Exception Procedures, the PADOH recognizes these volume concerns as part and parcel to offering PCI; in fact, as a means for hospitals to establish and maintain the highest level of quality and outcomes, the PA DOH requires both existing and new facilities to be formally accredited by a PADOH-approved accreditation body, such as Corazon.

Corazon is currently guiding more than half of the programs in Pennsylvania through the accreditation process and PADOH procedures. Moreover, Corazon provides PCI program implementation support, including regular on-site consultative services with a step-by-step methodical approach that assists programs with meeting and/or exceeding compliance standards.

One of these programs is Nazareth Hospital in Philadelphia, Pennsylvania. Daniel Bair, Administrative Director at Mercy Health System for the Cardiovascular and Radiology Service Line, contacted Corazon during the summer of 2014 to begin their accreditation process. The Nazareth team was successful in the initial accreditation survey and is now waiting for final approval from the PADOH deeming committee, which is expected by the end of October. Following the process, Dan explained, “The Corazon team was excellent in guiding our team through the PCI accreditation process. Their relationship with the state and knowledge of national best practice proved invaluable. The Nazareth team is extremely proud of what we have accomplished with PCI services and is thrilled to add this new recognition to the program.”

Another facility heavily invested in the outcomes of the consortium discussions was Hanover Hospital. Corazon had already been working with Kathy Miller, Administrative Director of the Heart and Vascular Center at Hanover, to establish a business plan for PCI service expansion. Before initiating any implementation services, however, the team wanted to fully understand the processes and requirements for new programs. According to Kathy, Hanover “had to understand what we were going to be held accountable for…There were too many variables and too many resources involved in the PCI program development to leave it up in the air. Luckily, our longstanding relationship with Corazon meant that we were immediately aware of the changes as they were taking shape at the state level. Corazon’s close involvement with the state allowed us to quickly initiate services on an expedited timeline.”

As a “new” program, and as defined by the PA PCI Exception Committee Procedures, Hanover Hospital became one of the first programs accredited for PCI in Pennsylvania. Only two months after launching the program, they are approaching 50 cases, and are projecting a very successful first year and beyond for the program. Kathy said, “It’s incredible…we are surpassing even the most aggressive scenarios projected in our business plan. Our team is just so proud to be able to offer PCI services in our community.”

Certainly, a financial impact is associated with offering PCI services; thus, Corazon strongly advises any programs considering an expansion to formally develop a business plan that would offer a “go” or “no go” decision for these services. In fact, this planning is also a requirement within the PCI Exception Procedures. Any new program is also required to provide the PADOH with a program development and implementation plan, including a timeline and business plan for reaching and maintaining volume of at least 200 procedures annually.

Looking ahead

This is an exciting time for cardiovascular services within the Commonwealth and across the country. The effects of change are becoming even more rapid as additional states are evaluating and changing PCI regulations, even as this article is published. For example, California has new regulations (California Senate Bill No. 906) set to go into effect in January 2015, which will allow PCI at a now-unlimited number of programs. California previously restricted PCI with off-site surgery to six hospitals within their pilot demonstration project.

Corazon strongly believes the time has come to “level the playing field” across the country, and Pennsylvania has now joined the many other states that permit PCI services with OHS offered off-site at a partner facility. We are pleased to be an integral part of this movement in serving as an official PADOH-approved accrediting body, and look forward to working with additional hospitals in the state and across the country to provide PCI expansion assistance, PCI program accreditation, or expert case review. Corazon can assist with PCI program requirements, quality assurance, and best practice operations to create an efficient and successful service line, even in states where accreditation is not mandated. In fact, our team has received several inquiries to perform PCI accreditation from facilities to evaluate the performance of their cath labs.

By increasing access to care without the addition of unnecessary services, hospitals everywhere can optimize their cardiac scope to bring needed services to their community — a goal worth pursuing regardless of location. With a standardized approach to PCI care across the country, beginning with concentrated efforts as seen here in Pennsylvania, coronary disease will claim far fewer lives, which is really the “heart” of the matter.